A Phase 2, Randomized, Double-Blind, Single Center, Parallel Group, Placebo and Active Comparator, Controlled Study to Evaluate the Pharmacodynamic Profile of Single Doses of SPD489 in Healthy Adult Male Subjects Undergoing a Nocturnal Period of Acute Sleep Loss.

Trial Profile

A Phase 2, Randomized, Double-Blind, Single Center, Parallel Group, Placebo and Active Comparator, Controlled Study to Evaluate the Pharmacodynamic Profile of Single Doses of SPD489 in Healthy Adult Male Subjects Undergoing a Nocturnal Period of Acute Sleep Loss.

Completed
Phase of Trial: Phase II

Latest Information Update: 01 Oct 2014

At a glance

  • Drugs Armodafinil; Lisdexamfetamine
  • Indications Sleep deprivation
  • Focus Pharmacodynamics
  • Sponsors Shire
  • Most Recent Events

    • 10 Jan 2011 Results have been announced in a Shire media release. The company plans to review potential development pathways with health authorities for lisdexamfetamine as a possible treatment for excessive daytime sleepiness.
    • 20 Jul 2010 Actual end date (Jul 2010) added as reported by ClinicalTrials.gov.
    • 20 Jul 2010 Status changed from recruiting to completed as reported by ClinicalTrials.gov.
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